Menstrual-phase-dependent Differences in Response to Sleep Loss

Sleep Deprivation Clinical Trial

Official title:

Menstrual-phase-dependent Differences in Response to Sleep Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381532
• Other study ID #: 2021P002586
• Secondary ID: R01HL162102
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2022
• Source: Brigham and Women's Hospital
• Contact: Melissa A St. Hilaire, PhD
• Phone: 6172780620
• Email: msthilaire[@]rics.bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.

Description:

During a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). Subjects will be randomly assigned to each study arm. During their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. Sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Female
• 18-35 years old
• Regular menstrual cycle between 26-35 days in duration
• Not using any form of hormonal contraception for at least the prior 3 months
• Regular sleep patterns (7-9 hours/night)
• Not taking any medications or supplements
• Weight >110 lb
• BMI between 18.5 and 29.5 kg/m2

Exclusion Criteria:

• Primary sleep disorder
• History of shift work
• Transmeridian travel in the previous 3 months
• Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders
• Current pregnancy, < 6 months postpartum, and/or breastfeeding
• Blood donation in the past 8 weeks
• Extreme morning or evening chronotype

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Behavioral:
• Controlled sleep
Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVT mean reaction time	The mean reaction time will be calculated across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT mean reaction time at each time point (multiple points across the study) across all 4 study arms.	The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Primary	PVT lapses in attention	The number of lapses in attention will be counted across each Psychomotor Vigilance Task (PVT) session. A linear mixed model analysis will be conducted to compare PVT lapses in attention at each time point (multiple points across the study) across all 4 study arms.	The PVT will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Primary	KSS score	The Karolinska Sleepiness Score (KSS) measures level of sleepiness on a 9-point Likert scale with 1 = Extremely Alert and 9 = Extremely Sleepy. A linear mixed model analysis will be conducted to compare KSS score at each time point (multiple points across the study) across all 4 study arms.	The KSS will be administered at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Primary	P4/E2 ratio	The ratio of progesterone (P4) and estradiol (E2) in each sample will be calculated as (P4 ng/ml x 1000)/E2 pg/ml. A linear mixed model analysis will be conducted to compare the P4/E2 ratio at each time point (multiple points across the study) across all 4 study arms.	Biological samples will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.
Primary	Core body temperature	Core body temperature is measured via rectal thermistor. A linear mixed model analysis will be conducted to compare the core body temperature at each time point (multiple points across the study) across all 4 study arms.	Core body temperature will be collected at frequent intervals over 11 days in a sleep laboratory. Subjects will be in a time-free environment, and not told the sampling frequency.